Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation
I. To determine if engraftment can be achieved safely in patients with high-risk hematologic
malignancies who undergo non-myeloablative bone marrow transplantation (BMT) from human
leukocyte antigen (HLA)-haploidentical donors.
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV)
over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients
undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and
then tacrolimus orally (PO), once tolerated, on days 4-180, with taper on day 86 in the
absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three
times daily on days 4-35.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 months and then annually
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Donor engraftment (chimerism)
Defined by the detection of more or greater than 50% donor T-cells (CD3+), as a proportion of the total T-cell population
At day +84
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
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